Analyte detection in physiological fluids, e.g., blood or blood derived products, physiological fluid, etc., is of ever increasing importance to today's society. Analyte detection assays find use in a variety of applications, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in diagnosis and management in a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol, and the like. In response to this growing importance of analyte detection, a variety of analyte detection protocols and devices for both clinical and home use have been developed.
In determining the concentration of an analyte in a physiological sample, a physiological sample must first be obtained. Obtaining the sample often involves cumbersome and complicated devices which may not be easy to use or may be costly to manufacture. Furthermore, the procedure for obtaining the sample may be painful. For example, pain is often associated with the size of the needle used to obtain the physiological sample and the depth to which the needle is inserted. Depending on the analyte and the type of test employed, a relatively large, single needle or the like is often used to extract the requisite amount of sample.
The analyte concentration determination process may also involve a multitude of steps. First, a sample is accessed by use of a skin-piercing mechanism, e.g., a needle or lancet, which accessing may also involve the use of a sample collection mechanism, e.g., a capillary tube. Next, the sample must then be transferred to a testing device, e.g., a test strip or the like, and then oftentimes the test strip is then transferred to a measuring device such as a meter. Thus, the steps of accessing the sample, collecting the sample, transferring the sample to a biosensor, and measuring the analyte concentration in the sample are often performed as separate, consecutive steps with various device and instrumentation.
Because of these disadvantages, it is not uncommon for patients who require frequent monitoring of an analyte to simply become non-compliant in monitoring themselves. With diabetics, for example, the failure to measure their glucose level on a prescribed basis results in a lack of information necessary to properly control the level of glucose. Uncontrolled glucose levels can be very dangerous and even life threatening.
Advances have been made in analyte detection technology to overcome the disadvantages of the above described testing protocols. A primary advancement is the integration of the means for accessing physiological fluid and the means for testing the fluid for the presence and/or concentration of the analyte of interest, e.g., glucose. More specifically, such integrated devices include a biosensor having a skin-piercing element, such as a microneedle, integrated therewith. Such exemplary devices are disclosed in, for example, the following U.S. patent application Ser. No. 09/923,093; U.S. application Ser. No. 10/143,442, entitled “Physiological Sample Collection Devices and Methods of Using the Same” and filed on the same day herewith; U.S. application Ser. No. 10/143,129, entitled “Analyte Test Element with Molded Lancing Blade” and filed on the same day herewith; and U.S. application Ser. No. 10/143,127, entitled “Methods of Fabricating Physiological Sample Collection Devices” and filed on the same day herewith.
Despite such advancements, there is a continued interest in the development of new devices and methods for use in the determination of analyte concentrations in a physiological sample. Of particular interest would be the development of analyte concentration determination systems having integrated fluid accessing and testing functions, and methods of use thereof, that are automated in order to minimize manipulation by the user, convenient, easy and discrete to use, involve minimal pain, and enhance portability.